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Bone & Joint Research
Vol. 5, Issue 6 | Pages 263 - 268
1 Jun 2016
Yan J MacDonald A Baisi L Evaniew N Bhandari M Ghert M

Objectives

Despite the fact that research fraud and misconduct are under scrutiny in the field of orthopaedic research, little systematic work has been done to uncover and characterise the underlying reasons for academic retractions in this field. The purpose of this study was to determine the rate of retractions and identify the reasons for retracted publications in the orthopaedic literature.

Methods

Two reviewers independently searched MEDLINE, EMBASE, and the Cochrane Library (1995 to current) using MeSH keyword headings and the ‘retracted’ filter. We also searched an independent website that reports and archives retracted scientific publications (www.retractionwatch.com). Two reviewers independently extracted data including reason for retraction, study type, journal impact factor, and country of origin.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims. Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. Methods. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive. Discussion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between surgical and non-surgical treatment of humeral shaft fractures. Ethical approval has been obtained from East of England – Cambridge Central Research Ethics Committee. Publication is anticipated to occur in 2024. Cite this article: Bone Jt Open 2024;5(4):343–349


Bone & Joint Open
Vol. 5, Issue 5 | Pages 411 - 418
20 May 2024
Schneider P Bajammal S Leighton R Witges K Rondeau K Duffy P

Aims. Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. Methods. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. Ethics and dissemination. This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication. Cite this article: Bone Jt Open 2024;5(5):411–418


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 51 - 51
14 Nov 2024
Shayestehpour H Shayestehpour MA Wong C Bencke J Rasmussen J
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Introduction. Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine with unclear etiology. Due to the asymmetry of lateral curves, there are differences in the muscle activation between the convex and concave sides. This study utilized a comprehensive thoracic spine and ribcage musculoskeletal model to improve the biomechanical understanding of the development of AIS deformity and approach an explanation of the condition. Methods. In this study, we implemented a motion capture model using a generic rigid-body thoracic spine and ribcage model, which is kinematically determinate and controlled by spine posture obtained, for instance, from radiographs. This model is publicly accessible via a GitHub repository. We simulated gait and standing models of two AIS (averaging 15 years old, both with left lumbar curve and right thoracic curve averaging 25 degrees) and one control subject. The marker set included extra markers on the sternum and the thoracic and lumbar spine. The study was approved by the regional Research Ethics Committee (Journal number: H17034237). Results. We investigated the difference between the muscle activation on the right and left sides including erector spinae (ES), psoas major (PS), and multifidus (MF). Results of the AIS simulations indicated that, on average throughout the gait cycle, the right ES, left PS and left MF had 46%, 44%, and 23% higher activities compared to the other side, respectively. In standing, the ratios were 28%, 40%, and 19%, respectively. However, for the control subject, the differences were under 7%, except ES throughout the gait, which was 17%. Conclusion. The musculoskeletal model revealed distinct differences in force patterns of the right and left sides of the spine, indicating an instability phenomenon, where larger curves lead to higher muscle activations for stabilization. Acknowledgement. The project is funded by the European Union's Horizon 2020 program through Marie Skłodowska-Curie grant No. [764644]


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 106 - 106
14 Nov 2024
Bliddal H Beier J Hartkopp A Conaghan P Henriksen M
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Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health Research Ethics committees. Twenty-seven participants completed the 4-year follow-up. The study evaluated WOMAC pain, stiffness, function, and Patient Global Assessment (PGA) of disease impact. Changes from baseline were analysed using a mixed model for repeated measurement (MMRM). Sensitivity analyses were applied on the extension data, where the MMRM analysis was repeated only including patients in the extension phase and an ANCOVA model was used, replacing missing values at 4-years with baseline values (BOCF). Results. The planned MMRM analysis (n=49) revealed a statistically significant decrease in WOMAC pain subscale scores (-22.0; 95%CI: -29.5; -14.4) from baseline to 4-years. Analysis of the extension phase (n=27) showed similar results (-21.8; 95%CI: -29.0; -14.6) compared to the initial analysis. Furthermore, BOCF analysis indicated a statistically significant reduction in WOMAC pain subscale scores from baseline (-13.0 units). Four new adverse events were reported between the 3-year and 4-year visits; none were related to treatment. Conclusions. This study shows that single injections of 6 ml intra-articular iPAAG were well tolerated and continued to provide clinically important effectiveness at 4-years after treatment. Acknowledgements. The study was sponsored by Contura International A/S


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 4 - 4
7 Aug 2024
Draper-Rodi J Abbey H Brownhill K Vogel S
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Purpose and Background. Guidelines recommend biopsychosocial care for chronic, complex musculoskeletal conditions, including non-specific low back pain. The aims were: 1/ to assess how patients with low back pain respond to osteopathic treatment, both before and after an osteopath has completed a Biopsychosocial Pain Management (BPM) course; and 2/ to assess if it is feasible and acceptable for osteopath participants to receive weekly SCED data and use it to guide patient management. Methods and Results. A multiple baseline single case experimental design trial (. clinicaltrials.gov. , on 18/10/2021, ID number NCT05120921) with 11 UK osteopaths was conducted. Patients were randomised to early, middle or late treatment start dates. Statistical analysis assessed the change between baseline, intervention and follow-up periods. Primary outcomes were the Numeric Pain Rating (NPR) and Patient Specific Function Scales (PSFS), measured during the baseline, the 6-week intervention, and during a 12-week follow-up period. At baseline, the osteopaths reported stronger biopsychosocial attitudes to pain, compared to biomedical beliefs (PABS: 34 behavioural scale; 29 biomedical scale). Overall, patient participants showed daily increases in symptoms during the pre-treatment phase (+0.24/day, p<0.001), and daily decreases during treatment (−2.94 over the treatment phase, p<0.001), which continued post-treatment (−3.36 over 12 weeks, p=0.04). Similar improvements were observed for function. Conclusion. Osteopathic care was shown to help patients with persistent low back pain. Patient recruitment was challenging because of the randomisation. With further development, the method shows feasibility as a means of enhancing research activity among practising clinicians. Previous presentations or publications of the work. The protocol was published (. https://doi.org/10.1016/j.ijosm.2023.100660. ) and presented at SBPR in 2022. The results were presented to an osteopathic conference in October 2023. Ethics approval was received from the University College of Osteopathy Research Ethics Committee. Conflicts of interests. Jerry Draper-Rodi receives fees from the sales of the e-learning course on the biopsychosocial management on the UCO CPD platform. Sources of funding. The research was funded by the Osteopathic Foundation


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 18 - 18
17 Nov 2023
Gallagher H Naeem H Wood N Daou HN Pereira MG Giannoudis PV Roberts LD Howard A Bowen TS
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Abstract. Introduction. Skeletal muscle wasting is an important clinical issue following acute traumatic injury, and can delay recovery and cause permanent functional disability particularly in the elderly. However, the fundamental mechanisms involved in trauma-induced muscle wasting remain poorly defined and therapeutic interventions are limited. Objectives. To characterise local and systemic mediators of skeletal muscle wasting in elderly patients following acute trauma. Methods. Experiments were approved by a local NHS Research Ethics Committee and all participants provided written informed consent. Vastus lateralis biopsies and serum samples were taken from human male and female patients shortly after acute trauma injury in lower limbs (n=6; mean age 78.7±4.4 y) and compared to age-matched controls (n=6; mean age 72.6±6.3 y). Atrogenes and upstream regulators (MuRF1; MAFbx; IL6, TNFα, PGC-1α) mRNA expression was assessed in muscle samples via RT-qPCR. Serum profiling of inflammatory markers (e.g. IL6, TNFα, IL1β) was further performed via multiplex assays. To determine whether systemic factors induced by trauma directly affect muscle phenotype, differentiated primary human myotubes were treated in vitro with serum from controls or trauma patients (pooled; n=3 each) in the final 24 hours of differentiation. Cells were then fixed, stained for myogenin and imaged to determine minimum ferret diameter. Statistical significance was determined at P<0.05. Results. There was an increase in skeletal muscle mRNA expression for E3 ligase MAFbx and inflammatory cytokine IL-6 (4.6 and 21.5-fold respectively; P<0.05) in trauma patients compared to controls. Expression of myogenic determination factor MyoD and regulator of mitochondrial biogenesis PGC-1α was lower in muscle of trauma patients vs controls (0.5 and 0.39-fold respectively; P<0.05). In serum, trauma patients showed increased concentrations of circulating pro-inflammatory cytokines IL-6 (14.5 vs. 0.3 pg/ml; P<0.05) and IL-16 (182.7 vs. 85.2 pg/ml; P<0.05) compared to controls. Primary myotube experiments revealed serum from trauma patients induced atrophy (32% decrease in diameter) compared to control serum-treated cells (P<0.001). Conclusion. Skeletal muscle from patients following acute trauma injury showed greater expression of atrophy and inflammatory markers. Trauma patient serum exhibited higher circulating pro-inflammatory cytokine concentrations. Primary human myotubes treated with serum from trauma patients showed significant atrophy compared to healthy serum-treated controls. We speculate a mechanism(s) acting via circulating factors may contribute to skeletal muscle pathology following acute trauma. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 78 - 78
1 Dec 2022
Willms S Matovinovic K Kennedy L Yee S Billington E Schneider P
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The widely used Fracture Risk Assessment Tool (FRAX) estimates a 10-year probability of major osteoporotic fracture (MOF) using age, sex, body mass index, and seven clinical risk factors, including prior history of fracture. Prior fracture is a binary variable in FRAX, although it is now clear that prior fractures affect future MOF risk differently depending on their recency and site. Risk of MOF is highest in the first two years following a fracture and then progressively decreases with time – this is defined as imminent risk. Therefore, the FRAX tool may underestimate true fracture risk and result in missed opportunities for earlier osteoporosis management in individuals with recent MOF. To address this, multipliers based on age, sex, and fracture type may be applied to baseline FRAX scores for patients with recent fractures, producing a more accurate prediction of both short- and long-term fracture risk. Adjusted FRAX estimates may enable earlier pharmacologic treatment and other risk reduction strategies. This study aimed to report the effect of multipliers on conventional FRAX scores in a clinical cohort of patients with recent non-hip fragility fractures. After obtaining Research Ethics Board approval, FRAX scores were calculated both before and after multiplier adjustment, for patients included in our outpatient Fracture Liaison Service who had experienced a non-hip fragility fracture between June 2020 and November 2021. Patients age 50 years or older, with recent (within 3 months) forearm (radius and/or ulna) or humerus fractures were included. Exclusion criteria consisted of patients under the age of 50 years or those with a hip fracture. Age- and sex-based FRAX multipliers for recent forearm and humerus fractures described by McCloskey et al. (2021) were used to adjust the conventional FRAX score. Low, intermediate and high-risk of MOF was defined as less than 10%, 10-20%, and greater than 20%, respectively. Data are reported as mean and standard deviation of the mean for continuous variables and as proportions for categorical variables. A total of 91 patients with an average age of 64 years (range = 50-97) were included. The majority of patients were female (91.0%), with 73.6% sustaining forearm fractures and 26.4% sustaining humerus fractures. In the forearm group, the average MOF risk pre- and post-multiplier was 16.0 and 18.8, respectively. Sixteen percent of patients (n = 11) in the forearm group moved from intermediate to high 10-year fracture risk after multiplier adjustment. Average FRAX scores before and after adjustment in the humerus group were 15.7 and 22.7, respectively, with 25% (n = 6) of patients moving from an intermediate risk to a high-risk score. This study demonstrates the clinically significant impact of multipliers on conventional FRAX scores in patients with recent non-hip fractures. Twenty-five percent of patients with humerus fractures and 16% of patients with forearm fractures moved from intermediate to high-risk of MOF after application of the multiplier. Consequently, patients who were previously ineligible for pharmacologic management, now met criteria. Multiplier-adjusted FRAX scores after a recent fracture may more accurately identify patients with imminent fracture risk, facilitating earlier risk reduction interventions


Bone & Joint Open
Vol. 2, Issue 3 | Pages 211 - 215
1 Mar 2021
Ng ZH Downie S Makaram NS Kolhe SN Mackenzie SP Clement ND Duckworth AD White TO

Aims. Virtual fracture clinics (VFCs) are advocated by recent British Orthopaedic Association Standards for Trauma and Orthopaedics (BOASTs) to efficiently manage injuries during the COVID-19 pandemic. The primary aim of this national study is to assess the impact of these standards on patient satisfaction and clinical outcome amid the pandemic. The secondary aims are to determine the impact of the pandemic on the demographic details of injuries presenting to the VFC, and to compare outcomes and satisfaction when the BOAST guidelines were first introduced with a subsequent period when local practice would be familiar with these guidelines. Methods. This is a national cross-sectional cohort study comprising centres with VFC services across the UK. All consecutive adult patients assessed in VFC in a two-week period pre-lockdown (6 May 2019 to 19 May 2019) and in the same two-week period at the peak of the first lockdown (4 May 2020 to 17 May 2020), and a randomly selected sample during the ‘second wave’ (October 2020) will be eligible for the study. Data comprising local VFC practice, patient and injury characteristics, unplanned re-attendances, and complications will be collected by local investigators for all time periods. A telephone questionnaire will be used to determine patient satisfaction and patient-reported outcomes for patients who were discharged following VFC assessment without face-to-face consultation. Ethics and dissemination. The study results will identify changes in case-mix and numbers of patients managed through VFCs and whether this is safe and associated with patient satisfaction. These data will provide key information for future expert-led consensus on management of trauma injuries through the VFC. The protocol will be disseminated through conferences and peer-reviewed publication. This protocol has been reviewed by the South East Scotland Research Ethics Service and is classified as a multicentre audit. Cite this article: Bone Jt Open 2021;2(3):211–215


Bone & Joint Open
Vol. 2, Issue 2 | Pages 79 - 85
15 Feb 2021
Downie S Stillie A Moran M Sudlow C Simpson AHRW

Aims. Surgery is often indicated in patients with metastatic bone disease (MBD) to improve pain and maximize function. Few studies are available which report on clinically meaningful outcomes such as quality of life, function, and pain relief after surgery for MBD. This is the published protocol for the Bone Metastasis Audit — Patient Reported Outcomes (BoMA-PRO) multicentre MBD study. The primary objective is to ascertain patient-reported quality of life at three to 24 months post-surgery for MBD. Methods. This will be a prospective, longitudinal study across six UK orthopaedic centres powered to identify the influence of ten patient variables on quality of life at three months after surgery for MBD. Adult patients managed for bone metastases will be screened by their treating consultant and posted out participant materials. If they opt in to participate, they will receive questionnaire packs at regular intervals from three to 24 months post-surgery and their electronic records will be screened until death or five years from recruitment. The primary outcome is quality of life as measured by the European Organisation for Research and the Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) C30 questionnaire. The protocol has been approved by the Newcastle & North Tyneside 2 Research Ethics Committee (REC ref 19/NE/0303) and the study is funded by the Royal College of Physicians and Surgeons of Glasgow (RCPSG) and the Association for Cancer Surgery (BASO-ACS). Discussion. This will be the first powered study internationally to investigate patient-reported outcomes after orthopaedic treatment for bone metastases. We will assess quality of life, function, and pain relief at three to 24 months post-surgery and identify which patient variables are significantly associated with a good outcome after MBD treatment. Cite this article: Bone Jt Open 2021;2(2):79–85


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 16 - 16
1 Nov 2021
Frydendal T Christensen R Mechlenburg I Mikkelsen LR Overgaard S Ingwersen KG
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Introduction and Objective. Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months. Materials and Methods. This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events. Results. The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158) in February 2019 and registration was performed at . ClinicalTrials.gov. (NCT04070027) in August 2019. Recruitment was initiated on the 2. nd. of September 2019 and the final deadline will be on the 30. th. of June 2021, or when a sample size of 120 patients has been accomplished. Conclusions. The results of the current trial are expected to enable evidence-based recommendations, which may be used to facilitate the shared-decision making process in the discussion of treatment strategy for the individual patient with severe hip OA. All results will be presented in peer-reviewed scientific journals and international conferences


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_4 | Pages 47 - 47
1 Apr 2018
Hughes E Williams R Cooke M Hall T Cox S Grover L
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Background. Bone is a hierarchically structured hard tissue that consists of approximately 70 wt% low-crystallinity hydroxyapatite. Intricate tubular channels, such as Haversian canals, Volkman's canals, and canaliculi are a preserved feature of bone microstructure. These structures provide pathways for vasculature and facilitate cell-to-cell communication processes, together supporting viability of cellular components and aiding in remodeling processes. Unfortunately, many commercial bone augmentation materials consist of highly crystalline phases that are absent of the structuring present within the native tissue they are replacing. This work reports on a the development of a novel bone augmentation material that is able to generate biologically analogous tubular calcium phosphate mineral structures from hydrogel-based spheres that can be packed into defects similar to those encountered in vivo. Experimental. Calcium loaded spheres were made by adding 5 wt% agar powder to 1 M calcium nitrate solutions, before heating the mixture to 80–90 oC and feeding droplets of gel into a reservoir of liquid nitrogen. Deposition of tubular mineral was initiated by exposure to ammonium phosphate solutions at concentrations between 500 mM and 1 M, and was characterized by micro-XRF mapping, XRD and SEM techniques. For an ex vivo model, human bone tissue was collected from patients undergoing elective knee replacement surgery. The United Kingdom National Research Ethics Service (East of Scotland Research Ethics Service) provided ethical approval (11/ES/1044). The augmented defect of the model was characterised by micro-XRF mapping and micro-CT techniques. Results and Discussion. Immersion of calcium-loaded hydrogel spheres in physiological solutions rich in phosphate promotes the release of calcium rich streams from the sphere surface, resulting in the precipitation of tubule structures. Micro-XRF mapping, XRD and SEM, revealed tubules possessed hierarchically structuring and consisted of low-crystallinity hydroxyapatite, making them analogous in composition and structure to incritate features of bone microstructure. When brought into close proximity with one another, spheres become fused in a matter of minutes by the entanglement and subsequent interstitial mineralisation of the mineral tubules. Micro-XRF mapping and micro-CT analysis of an augmented ex vivo human tissue defect model demonstrated the extensive deposition of low-crystallinity tubular mineral throughout a tissue defect. Conclusions. This is possibly the first example of a bone augmentation material that is able to generate biologically analogous structures in situ, and therefore may serve as a better scaffold for bone formation over synthetic alternatives. Moreover, the formation of structured mineral aids in achieving rapid hardening of the augmenting calcium-loaded hydrogel shperes within the defect space


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 22 - 22
1 Jun 2023
North A Stratton J Moore D McCann M
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Introduction. External fixators are attached to bones with percutaneous pins and wires inserted through soft tissues and bone increasing the risk of infections. Such infections compromise patient outcomes e.g., through pin loosening or loss, failure of fixator to stabilise the fracture, additional surgery, increased pain, and delayed mobilisation. These infections also impact the healthcare system for example, increased OPD visits, hospitalisations, treatments, surgeries and costs. Nurses have a responsibility in the care and management of patients with external fixators and ultimately in the prevention of pin-site infection. Yet, evidence on best practices in the prevention of pin-site infection is limited and variation in pin-site management practices is evident. Various strategies are used for the prevention of pin-site infection including the use of different types of non-medicated and medicated wound dressings. The aim of this retrospective study was to investigate the use of dry gauze or iodine tulle dressings for the prevention of pin-site infections in patients with lower limb external fixators. Methodology. A retrospective study of patients with lower limb external fixators who attended the research site between 2015–2022. Setting & Sample: The setting was the outpatient's (OPD) orthopaedic clinic in a University Teaching Hospital in Dublin, Ireland. Eligibility Criteria:. Over the age of 16, treated with an Ilizarov, Taylor Spatial frame (TSF) or Limb Reconstruction System (LRS) external fixators on lower limbs,. Pin-sites dressed with dry gauze or iodine tulle,. Those with pre-existing infected wounds close to the pin site and/or were on long term antibiotics were excluded. Follow Up Period: From time of external fixator application to first pin-site infection or removal of external fixator. Outcome Assessment: The primary outcome was pin-site infection, secondary outcomes included but were not limited to frequency of pin-site infection according to types of bone fixation, frequency of pin/wire removal and hospitalisation due to infection. Data analysis: IBM SPSS Version 25 was used for statistical analysis. Descriptive and inferential statistics were conducted as appropriate. Categorical data were analysed by counting the frequencies (number and percentages) of participants with an event as opposed to counting the number of episodes for each event. Differences between groups were analysed using Chi-square test or Fisher's exact test, where appropriate. Continuous variables were reported using mean and standard deviations and difference analysed using a two-sample independent t-test or non-parametric test (Mann-Whitney), where appropriate. Using Kaplan-Meier, survival analysis explored time to development of infection. Ethical approval: granted by local institute Research Ethics Committee on 12th March 2018. Results. During the study period, 97 lower limb external fixators were applied with 43 patients meeting the study eligibility criteria. The mean age was 38 (SD 14.1; median 37) and the majority male (n=32, 74%). At least 50% (n=25) of participants had an IIizarov fixator, with 56% (n=24) of all fixators applied to the tibia and fibula. Pin/wire sites were dressed using iodine (n=26, 61%) or dry gauze dressings (n=15, 35%). The mean age of participants in the iodine group was significantly higher than the dry gauze group (p=.012). The only significant difference between the iodine and dry gauze dressing groups at baseline was age. A total of 30 (70%) participants developed a pin-site infection with 26% (n=11) classified as grade 2 infection. Clinical presentation included redness (n=18, 42%), discharge (n=16, 37%) and pain (n=15, 35%). Over half of participants were prescribed oral antibiotics (n=28, 65%); one required intravenous antibiotics and hospitalization due to pin-site infection. Ten (23%) participants required removal of pin/wires; two due to pin-site infection. There was no association between baseline data and pin-site infection. The median time to developing an infection was 7 weeks (95%, CI 2.7 to 11.29). Overall, there were 21 (81%, n=26) pin-site infections in the iodine group and nine (60%, n=15) in the dry gauze group, difference in proportion and relative risk between the dressing groups were not statistically significant (RR 1.35, 95% CI 0.86–2.12; p= .272). There was no association between baseline data, pin-site infection, and type of dressing. Conclusions. At the research site, patients are referred to the OPD orthopaedic clinic from internal and external clinical sites e.g., from Hospital Consultants, General Practitioners and occasionally from multidisciplinary teams, throughout Ireland. Our retrospective observation study found that 97 lower limb external fixators were applied over a seven-year period which is lower than that reported in the literature. However, the study period included the COVID pandemic years (2020 and 2021) which saw a lower number of external fixators applied due to lack of theatre availability, cancelled admissions and social/travel restrictions that resulted in fewer accidents and lower limb trauma cases requiring external fixator application. The study highlighted a high infection rate with 70% of participants developing pin-site infection which is in keeping with findings reporting in other studies. Our study showed that neither an iodine nor dry gauze dressing was successful in preventing pin-site infection. In the iodine group 81% of participants developed infection compared to 60% in the dry gauze group. Given the lack of difference between the two groups consideration needs to be given to the continued use of iodine dressings in the prevention of pin-site infection. Pin-site infections result in a high portion of participants being prescribed antibiotics and, in an era, that stresses the importance of antimicrobial stewardship there is a need to implement effective infection prevention and control strategies that minimise infection. Further research is therefore needed to investigate more innovative medicated dressings such as those that contain anti-microbial or anti-bacterial agents


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 55 - 55
1 Mar 2021
Moore A Gooberman-Hill R
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In the UK and USA in 2016 more than 263,000 primary knee replacements were performed. Around 20% of patients report chronic post-surgical pain (CPSP) at three or more months after total knee replacement (TKR). A large proportion of adults with all types of chronic musculoskeletal pain do not use services for a number of reasons, despite being in constant or daily pain. Given the high prevalence of CPSP, there is potentially a large hidden population with an unexpressed need for care, experiencing ongoing pain and disability; understanding why they do not use health services may herald further insight into why many remain dissatisfied with knee replacement surgery. The aim of this study is to understand why some people with CPSP after TKR do not access services or make little use of healthcare. We conducted face-to-face in-depth interviews with 34 patients from 2 high-volume orthopaedic hospitals in England, to investigate their experience of long-term pain after knee replacement; their knowledge and understanding of CPSP; and their decisions about consulting for CPSP. The sample size was based on achievement of saturation and participants provided written informed consent. Interviews were transcribed and analysed using an inductive thematic approach with double coding for rigor. Ethical approval for the study was granted by the West Midlands Solihull Research Ethics Committee (15/WM/0469). A core theme within the analysis suggests that participants do not seek healthcare because they believe that nothing further can be done, either by themselves or by healthcare professionals. Surgeons' satisfaction with the knee surgery and reassurances that pain would improve, left patients feeling uncertain about whether to re-consult, and some assumed that further consultation could lead to further surgery or medication, which they wish to avoid. Some participants' comorbidities took precedence over their knee pain when seeking healthcare. Others felt they had received their “share” of healthcare resources and that others were more deserving of treatment. People's descriptions of pain varied, from dull, or aching to shooting pains. Many described their pain as “discomfort” rather than pain. The majority described pain that was better than their pre-surgical pain, though others described pain that was worse, which they believed to be nerve damage. Many expressed disappointment in the outcome of their TKR. Expectations of pain varied, where most had expected some post-surgical pain, others underestimated it, and some had expected to be completely pain free following their TKR. Our analysis suggests that the reasons that some people with CPSP after TKR do not consult are varied and complex, spanning psychosocial, structural, moral, and organisational domains. There was an overriding sense that further consultation would be futile or may lead to unwanted treatment. Results suggest that improved information for patients about CPSP and appropriate post-surgical healthcare services may help patients and clinicians to manage this condition more effectively


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 44 - 44
1 Dec 2020
Torgutalp ŞŞ Korkusuz F
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Background. Although there are predictive equations that estimate the total fat mass obtained from multiple-site ultrasound (US) measurements, the predictive equation of total fat mass has not been investigated solely from abdominal subcutaneous fat thickness. Therefore, the aims of this study were; (1) to develop regression-based prediction equations based on abdominal subcutaneous fat thickness for predicting fat mass in young- and middle-aged adults, and (2) to investigate the validity of these equations to be developed. Methods. The study was approved by the Local Research Ethics Committee (Decision number: GO 19/788). Twenty-seven males (30.3 ± 8.7 years) and eighteen females (32.4 ± 9.5 years) were randomly divided into two groups as the model prediction group (19 males and 12 females) and the validation group (8 males and 6 females). Total body fat mass was determined by dual-energy X-ray absorptiometry (DXA). Abdominal subcutaneous fat thickness was measured by US. The predictive equations for total fat mass from US were determined as fat thickness (in mm) × standing height (in m). Statistical analyses were performed using R version 4.0.0. The association between the total fat mass and the abdominal subcutaneous fat thickness was interpreted using the Pearson test. The linear regression analysis was used to predict equations for total body fat mass from the abdominal subcutaneous fat thickness acquired by US. Then these predictive equations were applied to the validation group. The paired t-test was used to examine the difference between the measured and the predicted fat masses, and Lin's concordance correlation coefficient (CCC) was used as a further measure of agreement. Results. There was a significant positive moderate correlation between the total fat mass and the abdominal subcutaneous fat thickness × height in the model prediction group of males (r = 0.588, p = 0.008), whereas significant positive very strong correlation was observed in the model prediction group of females (r = 0.896, p < 0.001). Predictive equations for DXA-measured total body fat mass from abdominal subcutaneous fat thickness using US were as follows: for males “Fat mass-DXA = 0.276 × (Fat thickness-US × Height) + 17.221” (R. 2. = 0.35, SEE = 3.6, p = 0.008); for females “Fat mass-DXA = 0.694 x (Fat thickness-US × Height) + 7.085” (R. 2. = 0.80, SEE = 2.8, p < 0.001). When fat mass prediction equations were applied to the validation groups, measured- and estimated-total fat masses in males and females were found similar (p = 0.9, p = 0.5, respectively). A good level of agreement between measurements in males and females was attained (CCC = 0.84, CCC = 0.76, respectively). Conclusion. We developed and validated prediction equations that are convenient for determining total fat masses in young- and middle-aged adults using abdominal subcutaneous fat thickness obtained from the US. The abdominal subcutaneous fat thickness obtained from a single region by US might provide a noninvasive quick and easy evaluation not only in clinical settings but also on the field


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 115 - 115
1 Jul 2020
Jhirad A Wohl G
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In osteoporosis treatment, current interventions, including pharmaceutical treatments and exercise protocols, suffer from challenges of guaranteed efficacy for patients and poor patient compliance. Moreover, bone loss continues to be a complicating factor for conditions such as spinal cord injury, prescribed bed-rest, and space flight. A low-cost treatment modality could improve patient compliance. Electrical stimulation has been shown to improve bone mass in animal models of disuse, but there have been no studies of the effects of electrical stimulation on bone in the context of bone loss under hormone deficiency such as in post-menopausal osteoporosis. The purpose of this study was to explore the effects of electrical stimulation on changes in bone mass in the ovariectomized rat model of post-menopausal osteoporosis. All animal protocols were approved by the institutional Animal Research Ethics Board. We developed a custom electrical stimulation device capable of delivering a constant current, 15 Hz sinusoidal signal. We used 30 female Sprague Dawley rats (12–13 weeks old). Half (n=15) were ovariectomized (OVX), and half (n=15) underwent sham OVX surgery (SHAM). Three of each OVX and SHAM animals were sacrificed at baseline. The remaining 24 rats were separated into four equal groups (n=6 per group): OVX electrical stimulation (OVX-stim), OVX no stimulation (OVX-no stim), SHAM electrical stimulation (SHAM-stim), and SHAM no stimulation (SHAM-no stim). While anaesthetized, stimulation groups received transdermal electrical stimulation to the right knee through bilateral skin-mounted electrodes (10 × 10 mm) with electrode gel. The left knee served as a non-stimulated contralateral control. The no-stimulation groups had electrodes placed on the right knee, but not connected. Rats underwent the stim/no-stim procedure for one hour per day for six weeks. Rats were sacrificed (CO2) after six weeks. Femurs and tibias were scanned by microCT focussed on the proximal tibia and distal femur. MicroCT data were analyzed for trabecular bone measures of bone volume fraction (BV/TV), thickness (Tb.Th), and anisotropy, and cortical bone cross-sectional area and second moment of area. Femurs and tibias from OVX rats had significantly less trabecular bone than SHAM (femur BV/TV = −74.1%, tibia BV/TV = −77.6%). In the distal femur of OVX-stim rats, BV/TV was significantly greater in the stimulated right (11.4%, p < 0 .05) than the non-stimulated contralateral (left). BV/TV in the OVX-stim right femur also tended to be greater than that in the OVX-no-stim right femur, but the difference was not significant (17.7%, p=0.22). There were no differences between stim and no-stim groups for tibial trabecular measures, or cortical bone measures in either the femur or the tibia. This study presents novel findings that electrical stimulation can partially mitigate bone loss in the OVX rat femur, a model of human post-menopausal bone loss. Further work is needed to explore why there was a differential response of the tibial and femoral bone, and to better understand how bone cells respond to electrical stimulation. The long-term goal of this work is to determine if electrical stimulation could be used as a complementary modality for preventing post-menopausal bone loss


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 113 - 113
1 Apr 2019
Gray H Guan S Young T Dowsey M Choong P Pandy M
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INTRODUCTION. The medial-stabilised (MS) knee implant, characterised by a spherical medial condyle on the femoral component and a medially congruent tibial bearing, was developed to improve knee kinematics and stability relative to performance obtained in posterior-stabilised (PS) and cruciate-retaining (CR) designs. We aimed to compare in vivo six-degree-of-freedom (6-DOF) kinematics during overground walking for these three knee designs. METHODS. Seventy-five patients (42 males, 33 females, age 68.4±6.6 years) listed for total knee arthroplasty (TKA) surgery were recruited to this study, which was approved by the relevant Human Research Ethics committees. Each patient was randomly- assigned a PS, CR or MS knee (Medacta International AB, Switzerland) resulting in three groups of 23, 26 and 26 patients, respectively. Patients visited the Biomotion Laboratory at the University of Melbourne 6±1.1 months after surgery, where they walked overground at their self-selected speed. A custom Mobile Biplane X-ray (MoBiX) imaging system tracked and imaged the implanted knee at 200 Hz. The MoBiX system measures 6-DOF tibiofemoral kinematics of TKA knees during overground gait with maximum RMS errors of 0.65° and 0.33 mm for rotations and translations, respectively. RESULTS AND DISCUSSION. Mean walking speeds for the three groups were not significantly different (PS, 0.86±0.14 m/s CR, 0.82±0.17 m/s and MS, 0.87±0.14 m/s, p>0.25). While most kinematic parameters were similar for the PS and CR groups, mean peak-to-peak anterior drawer was greater for PS (9.89 mm) than CR (7.75 mm, p=0.004), which in turn was greater than that for MS (4.43 mm, p<0.001). Mean tibial external rotation was greater for MS than PS (by 3.12°, p=0.033) and CR (by 3.34°, p=0.029). Anterior drawer and lateral shift were highly coupled to external rotation for MS but not so for PS and CR. The contact centres on the tibial bearing translated predominantly in the anterior-posterior direction for all three designs. Peak-to-peak anterior-posterior translation of the contact centres in the medial compartment was largest for PS (7.09 mm) followed by CR (5.45 mm, p=0.003) and MS (2.89 mm, p<0.001). The contact centre in the lateral compartment was located 2.5 mm more laterally for MS than PS and CR (p<0.001). The centre of rotation of the knee in the transverse plane was located in the medial compartment for MS and in the lateral compartment for both PS and CR. CONCLUSIONS. We quantitatively compared in vivo 6-DOF joint motion for PS, CR, and MS knees during locomotion. A higher degree of coupling between external rotation and anterior-posterior translation, greater constraint in the anterior-posterior direction, and a more medialised joint centre of rotation observed for the MS knees are explained by the highly congruent medial articulation characterising this design


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 2 - 2
1 May 2017
Green P Murray M Coxon A Ryan C Greenough C
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Background. The BACK To Health programme is part of the wider North of England back pain and radicular pain pathway. The purpose of this programme is to provide a CPPP approach based on the NICE guidelines CG88 for those with back pain that has not responded to early management and simpler therapies. The purpose of this study is to present preliminary results of this programme. Method. Referral onto the programme occurred through triage and treat practitioners or consultant clinics. A total of 44 patients were referred, with 31 attending the programme. The programme was delivered as a 3 week residential programme, with patients present 9am-5pm Monday to Thursday. A MDT provided an intense programme consisting of education, physical exercise, practical coping strategies and group discussion. The work has received ethical approval from the School of Health and Social Care Research Ethics and Governance committee at Teesside University. Results. Significant improvements (p<0.05) were seen in the, EQ-5D-5L, GAD-7, PHQ9, pain VAS scores (respective mean improvement 0.170, 5.2, 5.5 and 1.25). Significant improvement (p<0.05) was seen in ODI scores but with a mean improvement of 7% clinical significance was not achieved. Self-management confidence by the end averaged 6/10. Conclusion. The majority of patients showed good response to the BACK To Health Programme. After undergoing 3 weeks of education and exercise using cognitive behavioural principles early improvements were seen in GAD-7, PHQ9, Pain VAS and EQ/5D/5L. At 6 months and 1 year we will follow these patients up to continually assess progress. No conflicts of interest. No funding obtained


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 140 - 140
1 Apr 2019
Wakelin E Walter W Bare J Theodore W Twiggs J Miles B
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Introduction. Kinematics post-TKA are complex; component alignment, component geometry and the patient specific musculoskeletal environment contribute towards the kinematic and kinetic outcomes of TKA. Tibial rotation in particular is largely uncontrolled during TKA and affects both tibiofemoral and patellofemoral kinematics. Given the complex nature of post- TKA kinematics, this study sought to characterize the contribution of tibial tray rotation to kinematic outcome variability across three separate knee geometries in a simulated framework. Method. Five 50. th. percentile knees were selected from a database of planned TKAs produced as part of a pre-operative dynamic planning system. Virtual surgery was performed using Stryker (Kalamazoo, MI) Triathlon CR and PS and MatOrtho (Leatherhead, UK) SAIPH knee medially stabilised (MS) components. All components were initially planned in mechanical alignment, with the femoral component neutral to the surgical TEA. Each knee was simulated through a deep knee bend, and the kinematics extracted. The tibial tray rotational alignment was then rotated internally and externally by 5° & 10°. The computational model simulates a patient specific deep knee bend and has been validated against a cadaveric Oxford Knee Rig. Preoperative CT imaging was obtained, landmarking to identify all patient specific axes and ligament attachment sites was performed by pairs of trained biomedical engineers. Ethics for this study is covered by Bellberry Human Research Ethics Committee application number 2012-03-710. Results and Discussion. From the 360 Knee Systems database, 1847 knees were analysed, giving an average coronal alignment of 4.25°±5.66° varus. Five knees were selected with alignments between 4.1° and 4.3° varus. Kinematic outcomes were averaged over the 5 knees. The component geometries resulted in characteristically distinct kinematics, in which femoral rollback was most constrained by the PS components, whereas tibiofemoral axial rotation was most constrained in MS components. Patella lateral shift was comparable amongst all components in extension, medialising in flexion. Patella shift remained more lateral in MS components compared to PS and CR. Average patella lateral shift, medial and lateral facet rollback separated by tibial tray rotation are shown for all component systems in Figure 1. Medial and lateral facet rollback in the PS and CR components are symmetrical and opposite, indicating that with tibial tray rotation, the tibiofemoral articulation point balances between component rotation and neutral alignment, reflecting the restoring force exerted by the simulated collateral ligaments. As such, with higher internal tibial rotation and subsequent lateralisation of the tubercle, patella lateral shift increases. MS medial and lateral facet rollback however are not symmetrical nor opposite, reflecting the chirality of the tibiofemoral articulation. With internal tibial tray rotation, relatively high lateral facet rollback is observed, lateralising the femoral component centre, giving the patella component a relatively more medial position. Conclusions. Component geometry was found here to produce characteristically distinct tibiofemoral and patellofemoral kinematics. Medial stabilised components reported asymmetric kinematic changes, compared to either CR or PS components, in which a higher rate of change was observed for internal tray rotation, indicating that neutral or external rotation of medial stabilised components will result in more predictable kinematic outcomes


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 8 - 8
1 May 2017
Barlow T Scott P Griffin D Realpe A
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Background. There is a 20% dissatisfaction rate with knee replacements. Calls for tools that can pre-operatively identify patients at risk of being dissatisfied postoperatively have been widespread. However, it is unclear what sort of information patients would want from such a tool, how it would affect their decision making process, and at what part of the pathway such a tool should be used. Methods. Using focus groups involving 12 participants and in-depth interviews with 10 participants, we examined the effect outcome prediction has by providing fictitious predictions to patients at different stages of treatment. A qualitative analysis of themes, based on a constant comparative method, is used to analyse the data. This study was approved by the Dyfed Powys Research Ethics Committee (13/WA/0140). Results. Our results demonstrate several interesting findings. Firstly, patients who have received information from friends and family are unwilling to adjust their expectation of outcome down (i.e. to a worse outcome), but highly willing to adjust it up (to a better outcome). This is an example of the optimism bias, and suggests the effect on expectation of any poor outcome prediction would be blunted. Secondly, patients generally wanted a “bottom line” outcome, rather than lots of detail. Thirdly, patients who were earlier in their treatment for osteoarthritis were more likely to find the information useful, and for it to affect their decision, than patients later in their pathway. Conclusion. An outcome prediction tool would have most effect targeted towards people at the start of their treatment pathway, with a “bottom line” prediction of outcome. However, any effect on expectation and decision making of a poor outcome prediction is likely to be blunted by the optimism bias. Level of Evidence. 4